It’s been a decade since the America Invents Act (AIA) transformed the U.S. patent landscape from a first-to-invent to a first-inventor-to-file system and added new contours with the creation of the Patent Trial and Appeal Board (PTAB) to hear post-grant patent challenges outside of court. While the AIA’s inter partes review process and other post-grant procedures have helped weed out weak patents, they’ve also increased the uncertainty and unpredictability of many patents. Now, 10 years on, Congress is assessing how the PTAB has developed in real life and considering what course corrections may be needed.
Novartis AG is not going quietly into the night after the U.S. Court of Appeals for the Federal Circuit reversed itself, invalidating a method patent covering a dosing regimen for the company’s blockbuster multiple sclerosis drug, Gilenya (fingolimod). After the split opinion came down June 21 from the three-judge panel, Novartis said it planned to file a petition seeking further review of the decision by the full court.
A lengthy trial over two generic drug manufacturers’ alleged role in fueling the opioid epidemic in West Virginia came to an end this week when the U.S. affiliate of Teva Pharmaceuticals Ltd. and Allergan, now part of Abbvie Inc., agreed to a settlement totaling more than $161.5 million.
The commercial success of COVID-19 mRNA vaccines has other companies in the space “looking in the attic, so to speak,” to see if they have any patents they can assert against components of the vaccines so they can get a percentage of the sales, Aziz Burgy, a patent attorney, told BioWorld. Given the global spread of the pandemic and how quickly it came on, the vaccines have generated billions of dollars in sales in a short period of time, and other companies want a share, he said. He compared today’s patent infringement cases against the vaccine producers to the litigation seen in the early days of the smartphone revolution when other high-tech companies scrambled for a piece of Apple’s and Samsung’s profits.
Deciding not to roll the dice this time, Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. removed themselves April 18 from an ongoing opioid trial in West Virginia by agreeing to a $99 million settlement with the state.
A Purdue Pharma LP bankruptcy settlement is back on track now that the Sackler family has agreed to pay at least $5.5 billion, and up to $6 billion, for the role they played in the nationwide opioid epidemic.
Johnson & Johnson (J&J) and its U.S.-based Janssen Pharmaceutical Cos. reported that they have a sufficient level of participation to move forward with a $5 billion nationwide settlement to resolve opioid-related claims and litigation by states, cities, counties and other government subdivisions in the U.S.
The U.S. Federal Circuit’s denial Feb. 11 of an en banc rehearing in a case that could undermine label carveouts and slow the launch of generics is the topic of hallway chatter at this week’s annual conference of the Association for Accessible Medicines.
As part of a settlement in a class action suit, Vyera Pharmaceuticals LLC and its parent company, Phoenixus AG, of Baar, Switzerland, agreed last week to pay up to $28 million to a proposed class of third-party payers that covered Daraprim (pyrimethamine).
Market pressure for M&As in the life sciences sector and the U.S. government’s determination to crack down on anything that smells of antitrust could be on a collision course this year that’s likely to result in injunctions and a lot more litigation.
